Medline Convenience Kits Recall Issued
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Medline Industries, LP is recalling 113,843 convenience kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes outside the FDA-cleared 510(k).
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Medline Industries, LP initiated a voluntary recall after identifying unapproved design changes to the products outside of the 510(k) cleared by the FDA. The products were not initially reported in RES 98601. This is an ongoing Class II recall.
Which Products Are Affected
The recall covers Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes distributed under the following product descriptions and model numbers: ANGIO CATH COMBINED PACK DYNJ43609S, ANGIO PACK DYNJ67987D DYNJ80317A, ANGIO SPECIAL PROCEDURE-LF DYNJ38412C, ANGIOGRAM SET UP PACK DYNJ66260A, ANGIOGRAPHY PACK DYNJ44293I, ANGIOGRAPHY PACK-LF DYNJ0854485W, CARDIAC CATH PACK DYNJ82709, CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F, CATH LAB ANGIO TRAY DYNJ83506, CATH LAB PACK DYNJ66366C, MSC-GREEN BAY ST VINCENT SAMPC0686, NEUROLOGICAL CATH PACK DYNJ63434B, OR HYBRID-MRMC DYNJ907758B, STEWARD OR ANGIO PACK GSS DYNJ80925B. Specific UDI-DI and lot numbers are listed in the recall. A total of 113,843 kits are affected. Distribution was nationwide in the US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and Barbados.
What You Should Do
No specific consumer action steps are provided in the recall notice. The recall number is Z-2582-2026.
Why This Matters
The Class II recall involves 113,843 kits distributed across the United States and Barbados.
Source
FDA recall Z-2582-2026, report date 20260701.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,529 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.